1 Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.2 Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.3 Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours Hospital, Tours, France.4 INSERM, U1246, Tours, Franc Tours, France.5 Department of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.6 Saint Louis University Center for Abdominal Transplantation, MO, United States.7 Department of Internal Medicine, University of Vienna, Austria, Vienna.8 School of Medicine, University of Alabama Birmingham, AL.9 Department of Medicine, Mount Sinai Hospital, New York, NY.10 Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.11 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.12 Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.13 Department of Renal Medicine, Royal Prince Alfred Hospital, Central Clinical School, The University of Sydney, Sydney, Australia.14 Department of Medicine, The University of Chicago, Chicago, IL.15 Division of Nephrology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.

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Abstract

BackgroundGraft loss, a critically important outcome for transplant recipients, is variably defined and measured, and incompletely reported in trials. We convened a consensus workshop on establishing a core outcome measure for graft loss for all trials in kidney transplantation.MethodsTwenty-five kidney transplant recipients/caregivers and 33 health professionals from 8 countries participated. Transcripts were analyzed thematically.ResultsFive themes were identified. “Graft loss as a continuum” conceptualizes graft loss as a process, but requiring an endpoint defined as a discrete event. In “defining an event with precision and accuracy,” loss of graft function requiring chronic dialysis (minimum, 90 days) provided an objective and practical definition; retransplant would capture preemptive transplantation; relisting was readily measured but would overestimate graft loss; and allograft nephrectomy was redundant in being preceded by dialysis. However, the thresholds for renal replacement therapy varied. Conservative management was regarded as too ambiguous and complex to use routinely. “Distinguishing death-censored graft loss” would ensure clarity and meaningfulness in interpreting results. “Consistent reporting for decision making” by specifying time points and metrics (ie time to event) was suggested. “Ease of ascertainment and data collection” of the outcome from registries could support use of registry data to efficiently extend follow-up of trial participants.ConclusionsA practical and meaningful core outcome measure for graft loss may be defined as chronic dialysis or retransplant, and distinguished from loss due to death. Consistent reporting of graft loss using standardized metrics and time points may improve the contribution of trials to decision making in kidney transplantation.